Bladder CancerNCT00335491
Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
A study testing exercise intervention, complementary or alternative medicine procedure and fatigue assessment and management in people with Bladder Cancer and Breast Cancer, run by University of Utah at 1 site in United States.
Trial summary
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Bladder Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- exercise intervention, complementary or alternative medicine procedure and fatigue assessment and management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease
- At least moderate levels of fatigue and/or weakness
- Impaired mobility but ambulatory and medically able to participate in an exercise regimen
- No impaired knee flexion, defined as < 90º
PATIENT CHARACTERISTICS:
- Folstein Mini-Mental Status Examination score ≥ 23
- No extreme claustrophobia
- No diagnosed chronic fatigue syndrome/disorder
- No neurological impairments, including the following:
- Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease)
- Neurological insult (cerebrovascular attack) that manifests in a mobility disorder
- No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function
- No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica)
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior regular aerobic or resistance exercise
- Regular exercise defined as 2-3 times per week
- At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy )
- No concurrent cancer-related treatment other than hormonal therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A RENEW Intervention for Elderly Cancer Survivors
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
Read the detailed description
OBJECTIVES:
- Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
- Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
- Evaluate the patient's adherence to and satisfaction with the RENEW intervention.
OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
- Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Fatigue, Lung Cancer
- Being tested
- exercise intervention, complementary or alternative medicine procedure, fatigue assessment and management, physical therapy
- Keywords
- small cell lung cancer, non-small cell lung cancer, colon cancer, prostate cancer, breast cancer, male breast cancer, fatigue, lymphoma, ovarian epithelial cancer, bladder cancer, esophageal cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Fatigue, Lung Neoplasms, Lymphoma, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Also called Eccentron
12 weeks of 3x/week training on a recumbent eccentric stepper
complementary or alternative medicine procedureProcedure or surgery
Also called Eccentron
12 weeks of 3x/week training on the eccentron
fatigue assessment and managementProcedure or surgery
The visual analog scale will be used to assess muscle soreness from the previous exercise session
physical therapyProcedure or surgery
12 weeks of 3x/week training on the eccentron
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perception and pattern of change
To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status
Measured: 3 months of training followed by 6 and 12 months of no formal training
Secondary outcomes (1)
Structural and function changes
To explore whether changes in muscle structure and function (strength and power production and metabolic function) and mobility occur following twelve weeks of training with RENEW
Measured: 3 months of training followed by 6 and 12 months of no formal training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul LaStayo, University of Utah
- Investigators
- Paul C. LaStayo, PhD, PT, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335491
- Sponsor's protocol ID
- 14551
- Other IDs
- R21CA114523, P30CA042014, UUMC-R21CA114523
- Status last verified
- Sep 2011
- First submitted
- 8 Jun 2006
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
LaStayo PC, Marcus RL, Dibble LE, Smith SB, Beck SL. Eccentric exercise versus usual-care with older cancer survivors: the impact on muscle and mobility--an exploratory pilot study. BMC Geriatr. 2011 Jan 27;11:5. doi: 10.1186/1471-2318-11-5.
PubMed 21272338
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RENEW Intervention for Elderly Cancer Survivors
- ClinicalTrials.gov ID
- NCT00335491
- Acronym / sponsor ID
- 14551
- Conditions
- Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Fatigue, Lung Cancer
- Keywords
- small cell lung cancer, non-small cell lung cancer, colon cancer, prostate cancer, breast cancer, male breast cancer, fatigue, lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
Detailed description
OBJECTIVES:
- Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
- Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
- Evaluate the patient's adherence to and satisfaction with the RENEW intervention.
OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
- Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise interventionAlso: Eccentron12 weeks of 3x/week training on a recumbent eccentric stepper | Behavioural | – |
| complementary or alternative medicine procedureAlso: Eccentron12 weeks of 3x/week training on the eccentron | Procedure or surgery | – |
| fatigue assessment and managementThe visual analog scale will be used to assess muscle soreness from the previous exercise session | Procedure or surgery | – |
| physical therapy12 weeks of 3x/week training on the eccentron | Procedure or surgery | – |
Primary outcome
Patient perception and pattern of change
Time frame: 3 months of training followed by 6 and 12 months of no formal training
To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status
1 secondary outcome
Structural and function changes
Time frame: 3 months of training followed by 6 and 12 months of no formal training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
- Derived from this study: PubMed 21272338LaStayo PC, Marcus RL, Dibble LE, Smith SB, Beck SL. Eccentric exercise versus usual-care with older cancer survivors: the impact on muscle and mobility--an exploratory pilot study. BMC Geriatr. 2011 Jan 27;11:5. doi: 10.1186/1471-2318-11-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul C. LaStayo, PhD, PT principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, complementary or alternative medicine procedure and fatigue assessment and management in people with Bladder Cancer and Breast Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient perception and pattern of change (time frame: 3 months of training followed by 6 and 12 months of no formal training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2011; AzTrials last refreshed its copy on 28 Oct 2026.